Update: The following update relating to this announcement has been issued:

November 27, 2009 - See Notice NOT-MH-10-006 NIMH Announces Changes in NIMH Participation, As of January 8, 2010, NIMH will terminate or withdraw its participation from this FOA.

Program Announcement (PA) Number: PA-09-137

NOTICE: Applications submitted in response to this Funding
Opportunity Announcement (FOA) for Federal assistance must be submitted
electronically through Grants.gov (http://www.grants.gov)
using the SF424 Research and Related (R&R) forms and the SF424 (R&R)
Application Guide.

APPLICATIONS
MAY NOT BE SUBMITTED IN PAPER FORMAT.

This
FOA must be read in conjunction with the application guidelines included with
this announcement in Grants.gov/Apply
for Grants (hereafter called Grants.gov/Apply).

A
registration process is necessary before submission and applicants are highly
encouraged to start the process at least four (4) weeks prior to the grant submission
date. See Section IV.

Purpose. This Funding Opportunity Announcement (FOA) encourages Research
Project Grant (R01) applications to expand basic and translational
research on the processes and mechanisms involved in the experience,
expression, and regulation of emotion.

Mechanism of Support.This FOA will utilize the NIH Research Project Grant (R01) award
mechanism. Applications of identical scientific scope are encouraged also
under the NIH Small Research Grant (R03) and the NIH Exploratory/Developmental
Grant (R21) award mechanisms, responding to FOAs PA-06-180 and PA-06-181, respectively.

Funds Available and Anticipated
Number of Awards. Awards issued under this FOA
are contingent upon the availability of funds and the submission of a
sufficient number of meritorious applications.

Budget and Project Period.The total project period for an application
submitted in response to this funding opportunity may not exceed 5 years. Because the
nature and scope of the proposed research will vary from application to
application, it is anticipated that the size and duration of each award
will also vary.

Eligible Institutions/Organizations.Institutions/organizations listed in Section III.1.A. are eligible to apply.

Eligible Project Directors/Principal Investigators (PDs/PIs). IncludeIndividuals with the skills,
knowledge, and resources necessary to carry out the proposed research are
invited to work with their institution/organization to develop an application
for support. Individuals from underrepresented racial and ethnic groups as well
as individuals with disabilities are always encouraged to apply for NIH
support.

Number
of PDs/PIs. More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the
application.

Number
of Applications. Applicants may submit more than one application,
provided that each application is scientifically distinct.

Resubmissions.Applicants
may submit a resubmission application, but such application must include an
Introduction addressing the previous peer review critique (Summary Statement).
See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016).

Under this Funding Opportunity Announcement
(FOA), the National Institute of Mental Health (NIMH), National Cancer
Institute (NCI), National Institute on Aging (NIA), National Institute on
Alcohol Abuse and Alcoholism (NIAAA), National Institute of Child Health and Human Development (NICHD), and the National
Institute on Drug Abuse (NIDA), of the National Institutes of Health (NIH),
invite research grant applications that proposebasic or translationalresearch on
the processes involved in or mechanisms underlying
the experience, expression, and/or regulation of emotion.

The study of emotion encompasses a wide range of physiological,
psychological, social, cognitive, and developmental phenomena. Emotional
processes can be studied in human or animal subjects. Important
objects of study include, but are not limited to: 1) Central and peripheral
nervous system activity in the origins, expression, regulation and modulation
of emotion, 2) The contribution of emotional and motivational systems to
cognitive faculties such as perception, attention,
learning, and memory, 3) Investigations of overt behaviors, interpersonal
relationships, communication and decision making, 4) The environmental
circumstances and experiences that evoke and modulate different emotions.

This FOA encourages applications at both basic and translational levels. Basic topics of
interest include the interface between emotion and cognition, the development
of emotions and emotion regulation over the lifespan, and the neurobiological
systems involved in emotional function. Translational
topics of interest include understanding mechanisms involved in emotional
function in mental disorders, the mechanisms by which alcohol/drug dependence
and/or withdrawal affects emotions, and the ways individual differences in emotional function impact health behaviors,
health-related decision-making, and health outcomes.

The purpose of this FOA is to advance the study of emotion at a variety
of levels, using a broad range of techniques. Measurements of emotional correlates can be made at the behavioral, neural, and/or
physiological levels. Proposals which seek to combine these levels of analysis
are especially encouraged.

Outlined in this FOA are current research priorities, directed toward the
ultimate aims of fostering mental and physical health
throughout the lifespan. The sample research topics and questions provided
below are not intended to be exhaustive.

Basic Studies of Emotion

Basic studies of emotion include
tests of emotion theory, observations of emotion
phenomenology across time and/or context, and questions regarding the
interaction of emotion with other systems critical for mental and physical
health.

Sample research questions in this area include, but are not
limited to, the following:

What
are the continuities across, and distinctions among,
the phenomena of emotion, mood, and temperament? What social, psychological,
environmental, and biological factors mediate or modulate their
interrelationships? How do these phenomena interact in order to contribute to normal psychological and biological
development? What aspects of emotional states and dispositions are most clearly
associated with psychological well-being and mental health? How do these
interrelationships change with age?

What
are the basic mechanisms by which emotions are
acquired or otherwise shaped by physiological and social contexts? What are
the roles of parents, peers, siblings, teachers, care providers, and the media
in socializing emotion? How do these external socialization processes interact with the internal biological systems
underlying emotion and emotion regulation?

What
are the potential mechanisms by which sensation and perception interact with
emotion; and how do these interactions result in behavior? How do interactions between sensation, perception, and emotion modulate the
experience of physical or psychological pain, learning and memory, or cognitive
and social development?

What
are effects of sex/gender on emotion expression, perception and regulation?

How
do behavioral factors such as sleep quality, diet,
and physical activity affect emotion regulation and other aspects of emotional
function?

Biological Aspects

The study of emotion provides a valuable opportunity for
examination of the interplay between psychological,
physiological, and neural processes. Studies of interest include the role of
the central and peripheral nervous systems, the neuroendocrine system, and the
immune system in emotional experience and expression. Animal studies, including
the development of novel animal models or biomarkers,
are encouraged. Higher priority is given to interdisciplinary research that
investigates the linkages across levels of analysis, from behavioral to neural.

Sample research questions include, but are not limited to, the following:

· What
are the relations among the behavioral, physiological, and neural components of
emotion? What biological or behavioral consequences result when one or more
components is altered?

What
are the neuroanatomical circuits and neurochemical
processes involved in emotional states and traits?

What
are the neuroanatomical circuits and neurochemical processes involved in the
perception of emotion?

To
what extent do the neurobiological systems involved in emotion processing
overlap with those subserving cognitive functions?

How
do differences within the nervous system give rise to individual differences in
emotional reactivity and regulation?

To
what extent do the neurobiological systems involved in emotional expression or
perception overlap with those associated with
different psychiatric disorders?

What
are the bi-directional influences between emotional states or traits and
neurobiological, endocrine and immune systems?

What
role does physiological reactivity play in the experience and expression of emotion?

How
do the biological systems involved in emotion change over the lifespan? How
does the process of normal healthy aging affect the biological systems involved
in emotion? How do age-associated neurodegenerative diseases affect these systems?

How
do alcohol and drugs of abuse affect the biological systems involved in emotion
and emotion regulation? To what extent do these systems overlap with those
associated with a risk of alcohol/drug abuse? How are these systems involved in
alcohol/drug withdrawal- or craving-induced changes
in emotion?

Emotion and Cognition

A more detailed understanding is needed of the interface
between emotion and cognition. The relationship between these faculties
develops and changes over the lifespan. In addition,
many neuropsychiatric disorders include impairments in both emotion and
cognition (e.g., schizophrenia, depression, alcohol and drug abuse, Alzheimer's
disease, and autism). Understanding the developmental trajectories of these
impairments and whether they arise from disruptions
in common or distinct systems may be critical in directing future therapeutic
interventions. Such studies could also provide important data regarding the
ways in which individuals make economic, social, and health-related decisions over the life course. They could deepen our
understanding of risk-taking behaviors such as alcohol/drug abuse,
interpersonal violence, or sexual risk-taking. Such studies could help improve
cancer screening programs and cancer treatment strategies.

Sample research questions in this area include, but are not
limited to:

How
do cognitive processes act to regulate emotional states? In turn, how do
emotions serve to modulate cognitive abilities?

How
are behavioral and neurobiological mechanisms of
executive control and emotion regulation related? How do these functions
develop, interact, and change over the life course?

How
are behavioral and neurobiological mechanisms of perception, attention, and
emotion related?

How
does emotion affect reward processing, risk
perception, and decision-making?

How
does the understanding of emotions in self and others develop? How does this
understanding interact with perceptual and cognitive processes, and how does it
impact the experience, expression and regulation of
emotion?

What
is the role of motivation in driving emotional development and in shaping the
experience, expression or regulation of emotion over the lifecourse?

How
do changes in cognitive and emotional factors influence health-related
decision-making, adaptation to changes in health
status, or management of social relationships by older adults?

How
do emotion and cognition interact in order to contribute to psychopathology, alcohol/drug abuse, cancer screening
participation and treatment adherence, or quality of
life among individuals with physical or mental illnesses?

Developmental Aspects

Data on the development of emotions are accumulating
rapidly. An overarching theoretical framework addressing the ontogeny of
emotion could aid progress in this field. In many
psychiatric disorders, emotional dysfunction emerges during particular
developmental time periods. Understanding which neurobiological systems
underlie these symptoms, how the development of these systems differs in
patients with mental illness, and when the function
of these systems can be altered will help guide future therapeutic
interventions. Investigation of how developmental variables can best be modeled
pre-clinically is encouraged. Emotional development needs to be followed across the lifespan, including time points in infancy, early
and middle childhood, adolescence, adulthood, and old age.

Sample research questions in this area include, but are not
limited to, the following:

What
are the developmental time courses of different
emotions or emotional processing systems? How does brain development impact
emotional development? What neurobiological mechanisms are associated with
changes in emotional function that emerge over the lifecourse?

How
might emotions affect the endocrine, immune and
neural systems through development and aging?

How
do sex/gender-related differences in hormonal environment during development
affect the expression, perception or regulation of emotion?

Are
connections among the various components of emotions
present at birth? Do these change with age, particularly during periods of
transition (e.g., the transition to school, adolescence, parenting,
bereavement)? If so, how are these changes expressed? Do some changes
predispose toward psychopathology or alcohol/drug
abuse?

What
are the determinants, age- and sex-specific characteristics, and consequences
of emotional attachments across the lifespan? What are the parallels among
attachment patterns in infancy, in childhood, in adolescence, in adulthood, in old age?

How
do cognitive factors (e.g., intelligence, learning disabilities) influence the
development of emotional processes over the lifespan?

What
affective processes are particularly germane to coping with events in the
family life cycle (e.g., marriage, divorce, birth,
transition to parenthood, aging, retirement, dealing with death and
bereavement)?

What
are the developmental psychobiological contributions of stress, trauma, or
violence on emotional development, expression, and regulation?

Does
prenatal exposure to alcohol or drugs affect emotional development?
Conversely, are children with disorders of emotional regulation more vulnerable
to becoming alcohol or drug dependent?

Does
use or abuse of alcohol or drugs in adolescence affect emotion regulation? If so, how and by what mechanisms?

Social Aspects

The quality of interpersonal relationships can be a
significant source of both positive and negative emotions. Further, social
relationships play a substantial role in the modulation of emotional responses, however generated. Social factors
thus make a critical contribution to an understanding of emotion in mental
disorders, alcohol/drug abuse, and developmental disorders. In addition,
macro-environmental processes (e.g., culture, social
structure, the media) help shape emotional development and adjustment and may
provide useful insights into the field of emotion regulation. The new field of
social/affective neuroscience has been rapidly expanding; NIA, NIMH, and NIDA
remain especially committed to funding innovative
research in this area.

Sample research questions in this area include, but are not
limited to, the following:

How
do cultural and socialization processes influence the experience and expression
of emotion? How do salient social factors and
contexts (e.g., child care and school settings, media, exposure to violence) in
particular developmental stages shape emotional expression and regulation?

How
do variations in parenting style and behaviors influence the development of emotion regulation in children? How does child abuse or
neglect influence emotional development in children?

What
are the patterns of emotional communication within families and other intimate
groups? How do these patterns relate to the development, maintenance, or erosion of emotional bonds? How do variations
in the communication of emotions lead to differences in psychiatric diagnosis,
therapeutic approaches, and health outcomes?

How
are patterns of emotional communication altered by alcohol/drug abuse? How do emotions in the context of social relationships
affect treatment for alcohol/drug abuse? Conversely, how are they affected by
different types of alcohol/drug abuse treatment?

Among
cancer patients and their significant others, what are the short- and long-term consequences of different patterns of
emotional communication? How do variations in the communication of emotions
affect relationships with caregivers and psychological adjustment of patients,
significant others, and caregivers?

What
role does the process of social comparison play in
the emotional response to diseases (such as cancer) and to developmental
transitions (such as aging)? What are some potential mechanisms for the social
comparison process across individuals? How might these processes be influenced by other social or non-social
mechanisms?

How
does caregiver behavior influence affect regulation in persons with mental
disorders, alcohol/drug abuse, or Alzheimer's disease in late life? Conversely,
how do changes in emotional behavior and expression
associated with neurodegenerative disorders of late life impact emotional
reactivity and regulation in caregivers and family members?

How
do the emotions involved with social relationships affect life in the community
for severely disordered or disabled individuals?

How
can social variables be best modeled pre-clinically?

Individual Differences

Recent research suggests that
individual differences in emotional function may mark specific vulnerabilities
to mental disorders, including alcohol/drug abuse.
Individual differences in emotional reactivity and recovery may also play a
role in the development of stress-related disorders including chronic diseases
common to midlife and older age. A detailed examination of these individual
differences is critical for understanding the
etiology of various disorders and for designing prevention efforts.
Investigations are also needed to explore the determinants and consequences of
traits related to socioemotional function, such as infant temperament, risk tolerance, stress resilience and vulnerability,
impulsivity, and social bonding. Animal studies, including the development of
novel animal models, are encouraged.

Sample research questions in this
area include, but are not limited to, the following:

What are the biological
(including genetic) and experiential sources of individual differences in
emotional reactivity, emotion regulation, and emotional processing (e.g.,
memory, cognition)? How do these change during development? What are the
mechanisms by which biological and experiential
factors interact to affect emotional health?

To
what extent do individual differences in emotional states and traits arise from
differences in genetic make-up and/or epigenetic events?

Among children with
developmental disabilities, intellectual
disabilities, or medical illness, how are individual differences in
emotional processes related to functioning over time? Can targeted
treatment of emotional dysregulation in these children improve long-term
outcome? If so, how can these targeted
interventions best be accommodated within a treatment delivery system?

Do
individual differences in emotional reactivity and regulation, including
responses to stress, trauma, or low socioeconomic status produce differential
vulnerabilities to mental or developmental disorders,
alcohol/drug abuse, or chronic illnesses of middle- and older age?

How
do temperament, emotional regulatory style, and other emotional traits impact
the experience and management of physical symptoms such as pain, fatigue, and disability?

Among
alcohol/drug abusers, do individual differences in emotional reactivity and
regulation affect response to treatment?

Among
cancer patients or people at increased risk for cancer, how do individual
differences in emotional processes relate to fatigue,
resumption of activities of daily living, adherence to treatment, cancer
screening behaviors, family relationships, and patient-health care provider
relationships?

Translational Studies of Emotion

Translational studies of emotion
include the interactions between emotion and mental illness, alcohol/drug
abuse, developmental disorders, and physical disease. Emotional processes found
in psychopathology and developmental disorders may differ qualitatively or
quantitatively from normal emotional processes.
Emotion dysregulation may underlie many mental disorders, including
alcohol/drug abuse, and these disorders may further alter emotional states.
Physiological changes that accompany emotions may alter the course of medical
disorders directly; emotions may also alter disease
progression indirectly, by affecting treatment-related decisions or the ability
to cope with and manage symptoms.

Sample research questions in this area include, but are not
limited to:

What
are the continuities and discontinuities between
normative emotional processes (e.g., emotional development, expression,
understanding, awareness, communication, resilience) and emotional processes
seen in psychopathology, alcohol/drug abuse, or developmental disorders? Are there sex differences in the continuity/discontinuity of
these processes?

What
are the neural mechanisms that explain the association between emotion
dysregulation and some mental disorders? How can we define and use behavioral
phenotypes of emotion dysregulation to identify the
pathophysiology of related mental disorders? Are there sensitive periods in
brain development when this association can be altered?

What
are early behavioral or neurobiological signs of risk for mental disorders
among those with deficits in emotion processing?

How
is the atypical development of emotional capacities associated with the full
disease trajectory, from prodrome through onset to progression, recovery, and
relapse?

What
role does emotion play in stress diathesis models of
the etiology of mental disorders?

Does
identification and regulation of emotions decrease the risk of relapse in
physical or mental illness? What are the best ways to improve emotion
identification and regulation in different populations or patient groups?

Does
alcohol/drug use, abuse, or withdrawal produce changes in emotional
reactivity? If so, how? How is temperament associated with the risk ofalcohol/drug abuse? How do
stimuli associated with alcohol or drug use become triggers of emotional states that may lead to relapse? What role does emotion
regulation play in the treatment of alcohol/drug abuse? Investigation of these
questions at the pre-clinical level, in model systems, is encouraged.

To
what extent can behavioral, physiological, and neural
measures of emotion identify individuals at risk for suicidal, violent, or
self-injurious behavior? To what extent can these measures identify individuals
at risk for alcohol/drug abuse? To what extent can these measures be used to
monitor the effects of treatment?

What
is the role of emotion in decision-making related to cancer prevention,
detection or treatment? Do differences in emotional reactivity associated with
neural, immunological, or other biological pathways influence cancer risk or
prognosis? What are the effects of emotional
reactivity on cancer outcomes such as social relationships, health care
provider relationships, and treatment adherence?

How do developmental
disabilities or other pediatric disorders
affect the development of emotional reactivity or regulation? New approaches that integrate quantitative and
qualitative methods are needed to study these interactions.

What are the specific
emotional and behavioral differences in individuals with mental
retardation? New techniques are needed to assess
the impact of psychosocial stressors in the lives of people with mental
retardation and to integrate this knowledge with diagnostic protocols,
treatment strategies and service systems.

What
risk factors contribute to late-life emotional dysfunction?
How can late-life emotional dysfunction be prevented?

Methodological Needs

Methods related to the study of emotion run the full range,
from self-report and interview procedures, to behavioral observations and
assessments, to measures of central and peripheral
nervous system structure and function, to the development of novel animal
models. Improvements are needed in ways that enhance the validity and
efficiency of measurement without sacrificing richness and detail. In the
context of physical illnesses such as cancer,
methodology also is needed that takes into account the emotions of others in
the patient's social and medical environment. New techniques and analyses
should be sensitive to the changes in emotional responsiveness over time.

Sample needs in this area
include, but are not limited to, the following:

Most
research on emotional expression concentrates on the face. Methods also are
needed to assess and validate vocal, postural, and gestural components of
emotional expression. Further, measures of emotion
need to be developed that can be applied across settings, cultures, cohorts,
and species.

Techniques
of computer science, neural networks, and image processing need to be applied
to the task of producing valid and reliable judgments
of behavioral expressions of emotion.

Computational
models and other quantitative expressions of theories of emotions need to be
developed.

Improved
neuroimaging and large-array electrophysiological techniques are needed to
examine brain activity during different emotional
states. Further research is needed on the methodological and conceptual
relationships among techniques with different spatial and temporal resolution.

Animal
models need to be used to their fullest potential to examine social, cognitive, and biological determinants and consequences of
emotion.

Advanced
and ethically-guided human laboratory procedures for inducing both positive and
negative emotional states are needed.

Determination
of new ways to assess positive emotional functions such
as mastery, resilience, and self-efficacy are needed.

This FOA will use theNIH Research Project Grant (R01)award mechanism.The Project
Director/Principal Investigator (PD/PI) will be solely responsible for
planning, directing, and executing the proposed project.

This
FOA uses “Just-in-Time” information concepts (see SF424 (R&R)
Application Guide). It also uses the modular as
well as the non-modular budget formats (seehttps://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, a U.S. organization submitting an application with direct costs in each year of $250,000 or
less (excluding consortium Facilities and Administrative [F&A] costs)
should use the PHS398 Modular Budget component.

U.S. applicants requesting more than $250,000 in annual direct costs and all foreign
applicants must complete and submit budget requests using the Research &
Related Budget component.

2. Funds Available

Because the nature and scope of the proposed research
will vary from application to application, it is anticipated that the size and
duration of each award will also vary. Although the financial plans of the
IC(s) provide support for this program, awards pursuant to this funding
opportunity are contingent upon the availability of funds.

Facilities and Administrative (F&A) costs
requested by consortium participants are not included in the direct cost
limitation, see NOT-OD-05-004.

The decision of whether to apply for a grant with a
single PD/PI or multiple PDs/PIs grant is the responsibility of the
investigators and applicant organizations and should be determined by the
scientific goals of the project. Applications for grants with multiple PDs/PIs
will require additional information, as outlined in the instructions below. The
NIH review criteria for approach, investigators, and environment have been
modified to accommodate applications involving either a single PD/PI or
multiple PDs/PIs. When considering the multiple PD/PI option, please be aware
that the structure and governance of the PD/PI leadership team as well as the
knowledge, skills and experience of the individual PDs/PIs will be factored
into the assessment of the overall scientific merit of the application.
Multiple PDs/PIs on a project share the authority and responsibility for
leading and directing the project, intellectually and logistically. Each PD/PI
is responsible and accountable to the grantee organization, or, as appropriate,
to a collaborating organization, for the proper conduct of the project or
program, including the submission of required reports. For further information
on multiple PDs/PIs, please seehttps://grants.nih.gov/grants/multi_pi.

Number of Applications. Applicants may submit more
than one application, provided that each application is scientifically
distinct.

Resubmissions.Applicants
may submit a resubmission application, but such application must include an
Introduction. Beginning with applications intended for the January 25,
2009 official submission due date, all original new applications (i.e., never
submitted) and competing renewal applications will be permitted only a single
amendment (A1). See https://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html and NOT-OD-09-016 Original new and competing renewal applications
that were submitted prior to January 25, 2009 will be permitted two amendments
(A1 and A2). For these “grandfathered” applications, NIH expects that any A2
will be submitted no later than January 7, 2011, and NIH will not accept A2
applications after that date.

Renewals.Applicants may submit a competing
renewal application.

Section IV. Application and
Submission Information

To download a SF424 (R&R) Application Package and
SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for
this FOA, use the “Apply for Grant Electronically” button in this FOA or link
to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

The individual(s) designated as
PDs/PIs on the application must be registered also in the NIH eRA
Commons. In the case of multiple PDs/PIs, all PDs/PIs must be registered and
be assigned the PI role in the eRA Commons prior to the submission of the
application.

Each PD/PI must
hold a PD/PI account in the Commons. Applicants should not share a Commons
account for both an Authorized
Organization Representative/Signing Official (AOR/SO) role and a PD/PI role; however, if they have
both a PD/PI role and an Internet Assisted Review (IAR) role, both roles should
exist under one Commons account.

When multiple PDs/PIs are
proposed, all PDs/PIs at the applicant organization must be affiliated with
that organization. PDs/PIs located at another institution need not be
affiliated with the applicant organization, but must be affiliated with their
own organization to be able to access the Commons.

This registration/affiliation must
be done by the AOR/SO or his/her designee who is already registered in the
Commons.

Both
the PD(s)/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since
both are authorized to view the application image.

Several
of the steps of the registration process could take four weeks or more.
Therefore, applicants should immediately check with their business official to
determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept
electronic applications only from organizations that have completed all
necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R)
application forms and the SF424 (R&R) Application Guide for this FOA
through Grants.gov/Apply.

Note: Only the forms package directly attached to a
specific FOA can be used. You will not be able to use any other SF424 (R&R)
forms (e.g., sample forms, forms from another FOA), although some of the
"Attachment" files may be useable for more than one FOA.

Prepare
all applications using the SF424 (R&R) application forms and in accordance
with the SF424 (R&R) Application Guide for this
FOA through Grants.gov/Apply.

The
SF424 (R&R) Application Guide is critical to submitting a complete and
accurate application to NIH. Some fields within the SF424 (R&R) application
components, although not marked as mandatory, are required by NIH (e.g., the
“Credential” log-in field of the “Research & Related Senior/Key Person
Profile” component must contain the PD/PI’s assigned eRA Commons User ID).
Agency-specific instructions for such fields are clearly identified in the
Application Guide. For additional information, see “Frequently Asked Questions
– Application Guide, Electronic
Submission of Grant Applications.”

The
SF424 (R&R) application has several components. Some components are
required, others are optional. The forms package associated with this FOA in Grants.gov/APPLYincludes all applicable components, required and optional. A completed
application in response to this FOA includes the data in the following components:

Proposed research
should provide special opportunities for furthering research programs through
the use of unusual talent, resources, populations, or environmental conditions
in other countries that are not readily available in the United States (U.S.) or that augment existing U.S. resources.

SPECIAL
INSTRUCTIONS

Applications
with Multiple PDs/PIs

When
multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the
"Contact” PI, who will be responsible for all communication between the
PDs/PIs and the NIH, for assembling the application materials outlined below,
and for coordinating progress reports for the project. The contact PD/PI must
meet all eligibility requirements for PD/PI status in the same way as other
PDs/PIs, but has no other special roles or responsibilities within the project
team beyond those mentioned above.

Information
for the Contact PD/PI should be entered in item 15 of the SF424 (R&R) Cover
component. All other PDs/PIs should be listed in the Research &
Related Senior/Key Person component and assigned the project role of
“PD/PI.” Please remember that all PDs/PIs must be registered in the eRA
Commons prior to application submission. The Commons ID of each PD/PI
must be included in the “Credential” field of the Research & Related
Senior/Key Person component. Failure to include this data field will cause
the application to be rejected.

All projects proposing
Multiple PDs/PIs will be required to include a new section describing the
leadership plan approach for the proposed project.

Multiple PD/PI Leadership Plan: For applications designating
multiple PDs/PIs, a new section of the research plan, entitled “Multiple PD/PI
Leadership Plan” [Section 14 of the Research Plan Component in the SF424
(R&R)], must be included. A rationale for choosing a multiple PD/PI
approach should be described. The governance and organizational structure of
the leadership team and the research project should be described, and should
include communication plans, process for making decisions on scientific
direction, and procedures for resolving conflicts. The roles and
administrative, technical, and scientific responsibilities for the project or
program should be delineated for the PDs/PIs and other collaborators.

If
budget allocation is planned, the distribution of resources to specific
components of the project or the individual PDs/PIs should be delineated in the
Leadership Plan. In the event of an award, the requested allocations may be
reflected in a footnote on the Notice of Award (NoA).

Applications
Involving a Single Institution

When
all PDs/PIs are within a single institution, follow the instructions contained
in the SF424 (R&R) Application Guide.

Applications
Involving Multiple Institutions

When
multiple institutions are involved, one institution must be designated as the
prime institution and funding for the other institution(s) must be requested
via a subcontract to be administered by the prime institution. When submitting
a detailed budget, the prime institution should submit its budget using the
Research & Related Budget component. All other institutions should
have their individual budgets attached separately to the Research & Related
Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R)
Application Guide for further instruction regarding the use of the subaward
budget form.

When
submitting a modular budget, the prime institution completes the PHS398 Modular
Budget component only. Information concerning the consortium/subcontract
budget is provided in the budget justification. Separate budgets for each
consortium/subcontract grantee are not required when using the Modular budget
format. See Section 5.4 of the Application Guide for further instruction
regarding the use of the PHS398 Modular Budget component.

Applications may be submitted on or after the opening date and must be
successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted
by the due date(s) and time, the application may be delayed in the review
process or not reviewed.

Once an
application package has been successfully submitted through Grants.gov, any
errors have been addressed, and the assembled application has been created in
the eRA Commons, the
PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO)
have two weekdays (Monday – Friday, excluding Federal holidays) to view the
application image to determine if any further action is necessary.

If everything is acceptable, no further action is necessary. The
application will automatically move forward to the Division of Receipt and
Referral in the Center for Scientific Review for processing after two weekdays,
excluding Federal holidays.

Prior
to the submission deadline, the AOR/SO can “Reject” the assembled
application and submit a changed/corrected application within the two-day
viewing window. This option should be used if it is determined that some
part of the application was lost or did not transfer correctly during the
submission process, the AOR/SO will have the option to “Reject” the
application and submit a Changed/Corrected application. In these cases, please contact the eRA
Help Desk to ensure that the issues are addressed and corrected. Once
rejected, applicants should follow the instructions for correcting errors
in Section 2.12, including the requirement for cover letters on late
applications. The “Reject” feature should
also be used if you determine that warnings are applicable to your
application and need to be addressed now. Remember, warnings do not stop
further application processing. If an application submission results in
warnings (but no errors), it will automatically move forward after two
weekdays if no action is taken. Some warnings may need to be addressed
later in the process.

If
the two-day window falls after the submission deadline, the AOR/SO will have
the option to “Reject” the application if, due to an eRA Commons or Grants.gov
system issue, the application does not correctly reflect the submitted
application package (e.g., some part of the application was lost or didn’t
transfer correctly during the submission process). The AOR/SO should first
contact the eRA Commons Helpdesk to confirm the system error, document the issue, and
determine the best course of action. NIH will not penalize the applicant for an
eRA Commons or Grants.gov system issue.

If
the AOR/SO chooses to “Reject” the image after the submission deadline for a
reason other than an eRA Commons or Grants.gov system failure, a
changed/corrected application still can be submitted, but it will be subject to
the NIH
late policy guidelines and may not be accepted.
The reason for this delay should be explained in the cover letter attachment.

Both
the AOR/SO and PD/PI will receive e-mail notifications when the application is
rejected or the application automatically moves forward in the process after
two days.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review, NIH. Incomplete applications
will not be reviewed.

There will
be an acknowledgement of receipt of applications from Grants.gov and the Commons. The
submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the
PI receive Commons acknowledgments. Information related to the assignment of an
application to a Scientific Review Group is also in the Commons.

Note:
Since email can be unreliable, it is the responsibility of the applicant to
check periodically on their application status in the Commons.

The
NIH will not accept any application in response to this FOA that is essentially
the same as one currently pending initial merit review unless the applicant
withdraws the pending application. The NIH will not accept any application that
is essentially the same as one already reviewed. However, the NIH will accept a
resubmission application, but such application must include an Introduction
addressing the critique from the previous review.

All NIH awards are subject to the terms and
conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable. A grantee may, at its
own risk and without NIH prior approval, incur obligations and expenditures to
cover costs up to 90 days before the beginning date of the initial budget
period of a new or renewal award if such costs: 1) are necessary to conduct the
project, and 2) would be allowable under the grant, if awarded, without NIH
prior approval. If specific expenditures would otherwise require prior
approval, the grantee must obtain NIH approval before incurring the cost. NIH
prior approval is required for any costs to be incurred more than 90 days
before the beginning date of the initial budget period of a new or renewal
award.

The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on NIH either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. NIH expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project.
See NIH Grants Policy Statement https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

The applicant organization must include its DUNS
number in its Organization Profile in the eRA Commons. This DUNS number must
match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Frequently Asked Questions
– Application Guide, Electronic
Submission of Grant Applications.”

PHS398
Research Plan Component Sections

Page limitations of the PHS398 Research Plan component
must be followed as outlined in the SF424 (R&R) Application Guide. Although
each section of the Research Plan component needs to be uploaded separately as
a PDF attachment, applicants are encouraged to construct the Research Plan
component as a single document, separating sections into distinct PDF
attachments just before uploading the files. This approach will enable
applicants to better monitor formatting requirements such as page limits. All
attachments must be provided to NIH in PDF format, filenames must be included
with no spaces or special characters, and a .pdf extension must be used.

All application instructions outlined in the SF424
(R&R) Application Guide are to be followed, incorporating
"Just-in-Time" information concepts, and with the following additional
requirements:

Specific
Instructions for Applications Requesting $500,000 (direct costs) or More per
Year

Applicants requesting $500,000 or more in direct costs
for any year (excluding consortium F&A costs) must carry out the following
steps:

1) Contact the IC program staff at least 6 weeks
before submitting the application, i.e., as plans are being developed for the
study;

2)
Obtain agreement from the IC staff that the IC will accept the application for
consideration for award; and,

3) Include a cover letter with the application that
identifies the staff member and IC who agreed to accept assignment of the
application.

This policy applies to all new, renewal,
revision, or resubmission applications. See NOT-OD-02-004,
October 16, 2001.

Do not use the Appendix to circumvent the page
limitations of the Research Plan component. An application that does not comply
with the required page limitations may be delayed in the review process.

Resource
Sharing Plan(s)

NIH considers the sharing of unique research
resources developed through NIH-sponsored research an important means to
enhance the value and further the advancement of the research. When resources
have been developed with NIH funds and the associated research findings
published or provided to NIH, it is important that they be made readily
available for research purposes to qualified individuals within the scientific
community. If the final data/resources are not
amenable to sharing, this must be explained in the Resource Sharing section of
the application (see https://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.)

(b) Sharing Model Organisms:
Regardless of the amount requested, all applications in which the development
of model organisms is anticipated are expectedto include a
description of a specific plan for sharing and distributing unique model
organisms and related resources, or state appropriate reasons why such sharing
is restricted or not possible (see Sharing
Model Organisms Policy, and NIH
Guide NOT-OD-04-042.)

(c) Genome-Wide Association
Studies (GWAS): Regardless of the amount requested, applicants
seeking funding for a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designatedGWAS
data repository, or provide an appropriate explanation why submission to the
repository is not possible. A genome-wide association study is defined as
any study of genetic variation across the entire genome that is designed to
identify genetic associations with observable traits (e.g., blood pressure or
weight) or the presence or absence of a disease or condition. For further
information see Policy
for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide
Association Studies(NOT-OD-07-088) and https://grants.nih.gov/grants/gwas/.

Foreign Applications
(Non-domestic [non-U.S.] Entities)

Indicate how the proposed project has specific
relevance to the mission and objectives of the NIH/IC and has the potential for
significantly advancing the health sciences in the United States

Section V. Application Review
Information

1. Criteria

Only the review criteria described below will be
considered in the review process.

2. Review and
Selection Process

Applications
submitted for this funding opportunity will be assigned on the basis of
established PHS referral guidelines to the ICs for funding consideration.

Applications that are complete will be evaluated for
scientific and technical merit by (an) appropriate scientific review group(s) in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below.

As part of the scientific peer review, all
applications will:

Undergo a selection process in which
only those applications deemed to have the highest scientific and
technical merit, generally the top half of applications under review, will
be discussed and assigned a priority score;

Receive a written critique; and

Receive a second level of review by the appropriate national advisory council
or board.

Applications submitted in response to this funding
opportunity will compete for available funds with all other recommended
applications. The following will be considered in making funding decisions:

Scientific and technical merit of the
proposed project as determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to
program priorities.

The mission
of the NIH is to support science in pursuit of knowledge about the biology and
behavior of living systems and to apply that knowledge to extend healthy life
and reduce the burdens of illness and disability. As part of this mission,
applications submitted to the NIH for grants or cooperative agreements to
support biomedical and behavioral research are evaluated for scientific and
technical merit through the NIH peer review system.

Overall
Impact. Reviewers will provide an overall impact score
to reflect their assessment of the likelihood for the project to exert a
sustained, powerful influence on the research field(s) involved, in
consideration of the following five core review criteria, and additional review
criteria (as applicable for the project proposed).

Core Review
Criteria. Reviewers will consider each of the five
review criteria below in the determination of scientific and technical merit,
and give a separate score for each. An application does not need to be strong
in all categories to be judged likely to have major scientific impact. For
example, a project that by its nature is not innovative may be essential to
advance a field.

Significance. Does the project address an
important problem or a critical barrier to progress in the field? If the
aims of the project are achieved, how will scientific knowledge, technical capability,
and/or clinical practice be improved? How will successful completion of the
aims change the concepts, methods, technologies, treatments, services, or
preventative interventions that drive this field?

Investigator(s). Are the PD/PIs, collaborators,
and other researchers well suited to the project? If Early Stage Investigators
or New Investigators, do they have appropriate experience and training? If
established, have they demonstrated an ongoing record of accomplishments that
have advanced their field(s)? If the project is collaborative or multi-PD/PI,
do the investigators have complementary and integrated expertise; are their
leadership approach, governance and organizational structure appropriate for
the project?

Innovation. Does the
application challenge and seek to shift current research or clinical practice
paradigms by utilizing novel theoretical concepts, approaches or methodologies,
instrumentation, or interventions? Are the concepts, approaches or
methodologies, instrumentation, or interventions novel to one field of research
or novel in a broad sense? Is a refinement, improvement, or new
application of theoretical concepts, approaches or methodologies,
instrumentation, or interventions proposed?)

Approach. Are the overall strategy,
methodology, and analyses well-reasoned and appropriate to accomplish the
specific aims of the project? Are potential problems, alternative
strategies, and benchmarks for success presented? If the project is in the
early stages of development, will the strategy establish feasibility and will
particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?

Environment. Will the
scientific environment in which the work will be done contribute to the
probability of success? Are the institutional support, equipment and other
physical resources available to the investigators adequate for the project
proposed? Will the project benefit from unique features of the scientific
environment, subject populations, or collaborative arrangements?

Additional
Review Criteria. As applicable for the project proposed,
reviewers will consider the following additional items in the determination
of scientific and technical merit, but will not give separate scores for these
items.

Protections
for Human Subjects. For research that
involves human subjects but does not involve one of the six categories of
research that are exempt under 45 CFR Part 46, the committee will evaluate the
justification for involvement of human subjects and the proposed protections from
research risk relating to their participation according to the following five
review criteria: 1) risk to subjects, 2) adequacy of protection against risks,
3) potential benefits to the subjects and others, 4) importance of the
knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research
that involves human subjects and meets the criteria for one or more of
the six categories of research that are exempt under 45 CFR Part 46, the
committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials.

Inclusion
of Women, Minorities, and Children. When the
proposed project involves clinical research, the committee will evaluate the
proposed plans for inclusion of minorities and members of both genders, as well
as the inclusion of children.

Vertebrate
Animals. The committee will evaluate the involvement
of live vertebrate animals as part of the scientific assessment according to
the following five points: 1) proposed use of the animals, and species,
strains, ages, sex, and numbers to be used; 2) justifications for the use of
animals and for the appropriateness of the species and numbers proposed; 3)
adequacy of veterinary care; 4) procedures for limiting discomfort, distress,
pain and injury to that which is unavoidable in the conduct of scientifically
sound research including the use of analgesic, anesthetic, and tranquilizing
drugs and/or comfortable restraining devices; and 5) methods of euthanasia and
reason for selection if not consistent with the AVMA Guidelines on Euthanasia.

Resubmission
Applications. When reviewing a Resubmission application
(formerly called an amended application), the committee will evaluate the
application as now presented, taking into consideration the responses to
comments from the previous scientific review group and changes made to the
project.

Renewal
Applications. When reviewing a Renewal application
(formerly called a competing continuation application), the committee will
consider the progress made in the last funding period.

Revision
Applications. When reviewing a Revision application
(formerly called a competing supplement application), the committee will
consider the appropriateness of the proposed expansion of the scope of the
project. If the Revision application relates to a specific line of
investigation presented in the original application that was not recommended
for approval by the committee, then the committee will consider whether the
responses to comments from the previous scientific review group are adequate
and whether substantial changes are clearly evident.

Biohazards. Reviewers will assess whether materials or
procedures proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Additional
Review Considerations. As applicable for
the project proposed, reviewers will address each of the following items, but
will not give scores for these items and should not consider them in providing
an overall impact score.

Budget
and Period Support. Reviewers will
consider whether the budget and the requested period of support are fully
justified and reasonable in relation to the proposed research.

Select
Agent Research. Reviewers will assess the information
provided in this section of the application, including 1) the Select Agent(s)
to be used in the proposed research, 2) the registration status of all entities
where Select Agent(s) will be used, 3) the procedures that will be used to
monitor possession use and transfer of Select Agent(s), and 4) plans for
appropriate biosafety, biocontainment, and security of the Select Agent(s).

Applications
from Foreign Organizations.
Reviewers will assess whether the project presents special opportunities for
furthering research programs through the use of unusual talent, resources,
populations, or environmental conditions that exist in other countries and
either are not readily available in the United States or augment existing U.S. resources.

A formal notification in the form of a Notice of Award
(NoA) will be provided to the applicant organization. The NoA signed by the
grants management officer is the authorizing document. Once all administrative
and programmatic issues have been resolved, the NoA will be generated via email
notification from the awarding component to the grantee business official.

Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Section
IV.5., “Funding Restrictions.”

A final progress report, invention statement, and
Financial Status Report are required when an award is relinquished when a
recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding
opportunity and welcome the opportunity to answer questions from potential
applicants. Inquiries may fall into three areas: scientific/research (program),
peer review, and financial or grants management issues:

Human
Subjects Protection:Federal regulations (45 CFR 46) require that applications
and proposals involving human subjects must be evaluated with reference to the
risks to the subjects, the adequacy of protection against these risks, the
potential benefits of the research to the subjects and others, and the
importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data
and Safety Monitoring Plan:Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies
(Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative
trials (Phase III). Monitoring should be commensurate with risk. The
establishment of data and safety monitoring boards (DSMBs) is required for
multi-site clinical trials involving interventions that entail potential risks
to the participants (“NIH Policy for Data and Safety Monitoring,” NIH Guide for Grants and Contracts, https://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing
Research Data:Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include a
plan for data sharing or state why this is not possible (https://grants.nih.gov/grants/policy/data_sharing).Investigators should seek
guidance from their institutions, on issues related to institutional policies
and local institutional review board (IRB) rules, as well as local, State and
Federal laws and regulations, including the Privacy Rule. Reviewers will
consider the data sharing plan but will not factor the plan into the determination
of the scientific merit or the priority score.

Policy for Genome-Wide
Association Studies (GWAS):NIH is interested in
advancing genome-wide association studies (GWAS) to identify common genetic
factors that influence health and disease through a centralized GWAS data
repository. For the purposes of this policy, a genome-wide association study is
defined as any study of genetic variation across the entire human genome that
is designed to identify genetic associations with observable traits (such as blood
pressure or weight), or the presence or absence of a disease or condition. All
applications, regardless of the amount requested, proposing a genome-wide
association study are expected to provide a plan for submission of GWAS data to
the NIH-designated GWAS data repository, or provide an appropriate explanation
why submission to the repository is not possible. Data repository management
(submission and access) is governed by the Policy for Sharing of Data Obtained
in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see https://grants.nih.gov/grants/gwas/

Sharing of Model Organisms:NIH is committed to support efforts that encourage
sharing of important research resources including the sharing of model
organisms for biomedical research (see https://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of
grantees and contractors to elect and retain title to subject inventions
developed with Federal funding pursuant to the Bayh-Dole Act (see the NIH
Grants Policy Statement. Beginning October 1,
2004, all investigators submitting an NIH application or contract proposal are
expected to include in the application/proposal a description of a specific
plan for sharing and distributing unique model organism research resources
generated using NIH funding or state why such sharing is restricted or not
possible. This will permit other researchers to benefit from the resources
developed with public funding. The inclusion of a model organism sharing plan
is not subject to a cost threshold in any year and is expected to be included
in all applications where the development of model organisms is anticipated.

Access to Research Data through the Freedom of
Information Act:The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are: (1) first
produced in a project that is supported in whole or in part with Federal funds;
and (2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law (i.e., a regulation) may be
accessed through FOIA. It is important for applicants to understand the basic
scope of this amendment. NIH has provided guidance at https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this
funding opportunity in a public archive, which can provide protections for the
data and manage the distribution for an indefinite period of time. If so, the
application should include a description of the archiving plan in the study
design and include information about this in the budget justification section
of the application. In addition, applicants should think about how to structure
informed consent statements and other human subjects procedures given the
potential for wider use of data collected under this award.

Inclusion of Women And Minorities in Clinical
Research:It is the policy of the NIH that women and members of
minority groups and their sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification is
provided indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All
investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research” (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH
definition of clinical research; updated racial and ethnic categories in
compliance with the new OMB standards; clarification of language governing
NIH-defined Phase III clinical trials consistent with the SF424 (R&R)
application; and updated roles and responsibilities of NIH staff and the
extramural community. The policy continues to require for all NIH-defined Phase
III clinical trials that: a) all applications or proposals and/or protocols
must provide a description of plans to conduct analyses, as appropriate, to
address differences by sex/gender and/or racial/ethnic groups, including
subgroups if applicable; and b) investigators must report annual accrual and
progress in conducting analyses, as appropriate, by sex/gender and/or
racial/ethnic group differences.

Inclusion of Children as Participants in Clinical
Research:The NIH maintains a policy that children (i.e.,
individuals under the age of 21) must be included in all clinical research,
conducted or supported by the NIH, unless there are scientific and ethical
reasons not to include them.

Required Education on the Protection of Human Subject
Participants:NIH policy requires education on the protection of
human subject participants for all investigators submitting NIH applications
for research involving human subjects and individuals designated as key
personnel. The policy is available at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy,investigators
funded by the NIH must submit or have submitted for them to the
National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an
electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no
later than 12 months after the official date of publication. The
NIH Public Access Policy is available at (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html).For
more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable
Health Information:The Department of Health and Human Services (HHS)
issued final modification to the "Standards for Privacy of Individually
Identifiable Health Information", the "Privacy Rule", on August
14, 2002. The Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the protection
of individually identifiable health information, and is administered and
enforced by the HHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a
complete Regulation Text and a set of decision tools on "Am I a covered
entity?" Information on the impact of the HIPAA Privacy Rule on NIH
processes involving the review, funding, and progress monitoring of grants,
cooperative agreements, and research contracts can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All
applications and proposals for NIH funding must be self-contained within
specified page limitations. For publications listed in the appendix and/or
Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission
identification numbers must be used for publicly accessible on-line journal
articles. Publicly accessible on-line journal articles or PMC
articles/manuscripts accepted for publication that are directly relevant to the
project may be included only as URLs or PMC submission
identification numbers accompanying the full reference in either the
Bibliography & References Cited section, the Progress Report Publication
List section, or the Biographical Sketch section of the NIH grant application.
A URL or PMC submission identification number citation may be repeated in each
of these sections as appropriate. There is no limit to the number of URLs or
PMC submission identification numbers that can be cited.

Healthy People 2010:The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting
priority areas. This FOA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:This program is described in the Catalog of Federal Domestic Assistance athttp://www.cfda.gov/ and is not
subject to the intergovernmental review requirements
of Executive Order 12372. Awards are made under the authorization of Sections
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284)
and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. All
awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants
Policy Statement.

The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco products.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a facility) in
which regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.

Loan Repayment Programs:NIH encourages applications for educational loan
repayment from qualified health professionals who have made a commitment to
pursue a research career involving clinical, pediatric, contraception,
infertility, and health disparities related areas. The LRP is an important
component of NIH's efforts to recruit and retain the next generation of
researchers by providing the means for developing a research career unfettered
by the burden of student loan debt. Note that an NIH grant is not required for
eligibility and concurrent career award and LRP applications are encouraged.
The periods of career award and LRP award may overlap providing the LRP
recipient with the required commitment of time and effort, as LRP awardees must
commit at least 50% of their time (at least 20 hours per week based on a 40
hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.